[Congressional Record Volume 142, Number 117 (Friday, August 2, 1996)]
[Senate]
[Pages S9500-S9501]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                 CORRECTING THE ENROLLMENT OF H.R. 3103

  The PRESIDING OFFICER. The clerk will now report the concurrent 
resolution.
  The bill clerk read as follows:

       A concurrent resolution (S. Con. Res. 68) to correct the 
     enrollment of H.R. 3103.

  The PRESIDING OFFICER. Under the previous order, the concurrent 
resolution is agreed to.

[[Page S9501]]

  The concurrent resolution (S. Con. Res. 68) was agreed to as follows:

                            S. Con. Res. 68

       Resovled by the Senate (the House of Representatives 
     concurring), that in the enrollment of the bill (H.R. 3103 
     entitled ``an Act to amend the Internal Revenue Code of 1986 
     to improve portability and continuity of health insurance 
     converge in the group and individual markets, to combat 
     waste, fraud, and abuse in health insurance and health care 
     delivery, to promote the use of medical savings account, to 
     improve access to long-term care services and coverage, to 
     simplify the administration of health insurance, and for 
     other purposes'', the Clerk of the House of Representatives 
     shall make the following correction:
       Strike subtitle H of title II.

  Mr. KENNEDY. Mr. President, I wish to make a brief comment on the 
addition of the special-interest provision that was added in the 
legislation without knowledge of the Democratic conferees and, to my 
knowledge, Republican conferees.
  I am pleased that a provision to benefit a particular pharmaceutical 
company will now be dropped from the very important health care 
legislation.
  The provision was surreptitiously included in the conference report 
without the knowledge of the conferees. Clearly, it did not belong in 
this legislation.
  I simply point out that the provision was rejected when previous 
efforts to put it into other bills were attempted. An initial attempt 
to include the special deal was rejected in the defense authorization 
bill. A second attempt was made to include it in the agriculture 
conference report, and that was rejected also. Now it has been rejected 
in the health reform conference, and we were right to reject it.
  Let me just conclude by saying, strike three, this provision is out 
and good riddance.
  I will highlight the points in the GAO report that was issued. It 
said that Lodine is a ``me, too'' drug which provides no significant 
health benefit or therapeutic breakthrough which would justify 
expedited review, such as AIDS or cancer.
  FDA found that the Lodine submission was ``piecemeal, voluminous, 
disorganized, and based on flawed clinical studies.''
  The Lodine submission to FDA did not contain ``enough data to prove 
efficacy, until September 1989.''
  It has already received special consideration under the Waxman-Hatch 
amendments. We passed that to try to take into consideration companies 
that felt they had not been treated fairly before the FDA. We have 
included in the Record the excellent statement that has been made by 
both Senator Chafee and Senator Pryor. First of all, we note that no 
hearings or deliberations of any kind have been held in either the 
House or Senate as to whether any public purpose would be served by 
granting this extension. Then, finally, the CBO says the patent 
extension will cost the Federal Government and taxpayers $10 million. 
These resources would be far better applied and are urgently needed 
under the submissions jurisdiction.
  The other point I will mention, the Lodine patent extension includes 
language barring importation of active ingredients. This would prevent 
generic competitors from conducting the essential preclinical tests and 
clinical studies to prepare for marketing, as they are permitted and 
required under the 1984 act. This specific clause further extends the 
patent extension by as much as 5 years and market exclusivity by as 
much as 7 years.

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